The 21st Century Cures Act, under the leadership of Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), was signed into law in December 2016. Now, Reps. Upton and DeGette are drafting follow up legislation, known as “Cures 2.0” and are soliciting input. Heart Valve Voice US will be tracking this legislation and our current areas of interest include:
- Establishment of a Federal grant program for organizations that work to provide support and other resources for patients and families during a pandemic;
- Authorization of grants for educational programs and training for care partners to learn skills which would allow them to augment a care team;
- Establishment of an automatic communication requirement between FDA and CMS for products granted Breakthrough Therapy designations. This would potentially shorten the time period between when a product is approved by the FDA and covered under Medicare, allowing therapies that show a substantial improvement over existing therapies to reach patients sooner;
- Modernizing the reimbursement rules for medical products. These rules have often not kept pace with the many innovations in heart valve technologies, which can impose unnecessary requirements and delay access for patients.